Roger Leclerc, Senior Director
Regulatory Affairs & Export Development

Roger brings many years of experience as Regulatory Affairs Consultant in manufacturing, design, and quality management. He has more than 15 years of regulatory affairs, quality assurance, and marketing experience in the medical devices technology industry. Roger has been responsible for increasing awareness of the Program for Export Market Development (PEMD) among medical device companies while working as Director of regulatory Affairs at Medical Devices Canada (MEDEC).

He also has many years of experience in regulatory affairs and operations/manufacturing in Canada and at the international level. He has been actively involved with the handling of regulatory and export issues with medical device companies and various government agencies. (Health Canada, Medical Device Bureau, Industry Canada, and International Trade Canada, USA, Europe, Japan and China).

Roger is a Certified Lead Auditor and has extensive knowledge with the implementation of the Canadian, European, and US Medical Device Regulations. His involvement with the Society of Manufacturing Engineers Association and expertise with machine vision technologies elected him to Chapter Member.
 
He was a member of the Medical Device Regulation Global Harmonization Task Force (GHTF) for the harmonization of the Medical Device Regulations. Roger was also a member of the Canadian Standard Association (CSA) a Strategic Steering Committee on Health Care Technology (HCT) and Canadian Advisory Committee (CAC) TC 210 on Quality Management.

Roger is a graduate of Business Administration, Quality Management, and Industrial Engineering. He received his education from Hearst University and Centennial College of Applied Arts and Technology. Over the past several years he has worked for multi nationals in the automotive, electronic, and medical device industry in various senior positions.